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    Corrective and Preventive Actıons Procedure

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    evrim korı
    This document outlines a procedure for corrective and preventive actions (CAPA) to address nonconformities with quality standards. It defines responsibilities for notifying, investigating, implementing, and closing out CAPAs. Potential nonconformities may be identified through audits, complaints, meetings, or other means. The root cause is analyzed and a plan is made to address it. Actions are documented, tracked to completion, and records are maintained for three years. The goal is to remove causes of nonconformities and prevent reoccurrence.

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    Corrective and Preventive Actıons Procedure

    Uploaded by

    evrim korı
    866 views4 pages
    This document outlines a procedure for corrective and preventive actions (CAPA) to address nonconformities with quality standards. It defines responsibilities for notifying, investigating, implementing, and closing out CAPAs. Potential nonconformities may be identified through audits, complaints, meetings, or other means. The root cause is analyzed and a plan is made to address it. Actions are documented, tracked to completion, and records are maintained for three years. The goal is to remove causes of nonconformities and prevent reoccurrence.

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    Corrective and Preventive Actıons Procedure

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    This document outlines a procedure for corrective and preventive actions (CAPA) to address nonconformities with quality standards. It defines responsibilities for notifying, investigating, implementing, and closing out CAPAs. Potential nonconformities may be identified through audits, complaints, meetings, or other means. The root cause is analyzed and a plan is made to address it. Actions are documented, tracked to completion, and records are maintained for three years. The goal is to remove causes of nonconformities and prevent reoccurrence.

    Copyright:

    © All Rights Reserved
    Download as DOC, PDF, TXT or read online from Scribd
    Download as doc, pdf, or txt
    866 views4 pages

    Corrective and Preventive Actıons Procedure

    Uploaded by

    evrim korı
    This document outlines a procedure for corrective and preventive actions (CAPA) to address nonconformities with quality standards. It defines responsibilities for notifying, investigating, implementing, and closing out CAPAs. Potential nonconformities may be identified through audits, complaints, meetings, or other means. The root cause is analyzed and a plan is made to address it. Actions are documented, tracked to completion, and records are maintained for three years. The goal is to remove causes of nonconformities and prevent reoccurrence.

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    © All Rights Reserved
    Download as DOC, PDF, TXT or read online from Scribd
    Download as doc, pdf, or txt
    of 4
    At a glance
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    The key takeaways from this procedure are that it outlines a process for investigating nonconformities, determining their root causes, planning and implementing corrective actions to prevent reoccurrence.

    The aim of this procedure is to define the method of actions to investigate the root causes of potential and existing nonconformities about ISO 9001:2008, OHSAS 18001:2007, ISO 14001:2004 Standards in order to remove these root causes and prevent reoccurrence.

    The main steps involved in the corrective and preventive action process according to this procedure are notification of the nonconformity, conducting a root cause analysis, planning corrective actions, implementing the actions, verifying effectiveness, and closing out the action.

    CORRECTIVE AND PREVENTIVE

    ACTIONS PROCEDURE

    REVISION FOLLOW-UP PAGE

    Rev. No 0 1 2 3 4 5 6 7 8

    Date 01.03.10 28.05.10


    The updated and valid version of this document can be seen on the monitor. Hard copies will not be valid in the case that the copies do
    not have “Controlled Copy” cachet.

    1. AIM

    The aim of this procedure is to define the method of actions to investigate the root causes of potential and
    existing unconformities about ISO 9001:2008, OHSAS 18001:2007, ISO 14001:2004 Standards in ., to
    remove these root causes to prevent the occurrence or reoccurrence.

    2. SCOPE

    This procedure involves all processes and departments within the Integrated Management System.

    3. RELATED DOCUMENTS

     Incident Review Procedure


     Nonconforming Product/ Service Control Procedure
     Customer Satisfaction Procedure
     Environmental Impact and OHS Risk Assessment Procedure

    4. DEFINITIONS

    Corrective Action: Actions to remove the root cause of the unconformity and avoid reoccurrence.

    Preventive Action: Actions done in advance to remove and dispose the root cause of a potential
    unconformity and avoid reoccurrence.

    5. RESPONSIBILITIES and IMPLEMENTATION

    5.1 Notification of Corrective and Preventive Actions

    Corrective and Preventive Actions can be determined during but not limited to the following activities.

     Customer Complaints and Feedbacks


     Internal/Eternal Audits
     Management Review Meeting
     Measurement and Verification Activities
    CORRECTIVE AND PREVENTIVE
    ACTIONS PROCEDURE

     Employee Feedbacks
     Development and Improvement Meetings
     EOHS Assembly
     Creation of Aim – Target and Management Program
     Evaluation of the Conformity according to the Legal Requirements

    Corrective actions are started by the persons who made the examination about the unconformities
    determined during the activities listed above. CAPA is initiated based on evidence. Evidence contains
    information such as photos taken, related reports, records (forms, tables), place where the unconformity is
    detected and/or the description of the situation.

    Before CAPA, Environmental Impact and OHS Risk Assessment are made. If HSE Admin deems
    necessary, action is planned and precautions are taken.

    5.2 Realization of Corrective and Preventive Actions


    CAPA is open by the person who made the determination. Nonconformity is defined based on evidence in
    CAPA Form. Person who made the determination conveys the form to Quality Manager for the follow-up,
    monitoring and control. Quality Manager records CAPA in CAPA Form. Quality Manager submits CAPA
    Form to the person who will realize the action.
    Person in charge of the action determines the result of the root cause analysis, CAPA and scheduled time,
    and signs the form. After that, he/she conveys a photocopy of the form to the Quality Manager. Quality
    Manager revises CAPA Form and transmits it to the person who made the determination for the follow-up.
    Quality/ HSE Admin controls whether the action is fulfilled in scheduled time as it is identified in CAPA
    Form.

    5.3 Implementation of Root Cause Analysis


    Root cause analysis is made to remove the source of nonconformity and its reoccurrence. Person in
    charge of the action determines the root cause of the nonconformity. Root Cause Analysis Form and
    fishbone diagram is used for the analysis if necessary. If fishbone diagram is used, root cause is
    determined as follows:
    In fishbone diagram, root cause is investigated in 4 main categories based on the definition of
    nonconformity. 4 main categories are composed of “Ambient Conditions, Equipment/ Material Faults,
    Human Fault, Method Fault”. Related category is being asked “Why” for the situation defined as
    nonconformity. Every answer that is given for the question “Why” is again being asked “Why”. This is
    repeated at least 5 times. Root cause is attained in 5 questions according to the root cause analysis
    method.

    1. While evaluating Human Fault, evaluation is made but not limited to the following activities;
     Orientation trainings
     Job trainings
     Work in compliance with Procedures/ Instructions

    2. While evaluating Ambient Conditions, evaluation is made but not limited to the following activities;
    CORRECTIVE AND PREVENTIVE
    ACTIONS PROCEDURE

     Lighting-dust-gas-noise
     Thermal conditions
     Nonconformity with ground-space
     Conformity with storage conditions
     Chemical Leakages

    3. While evaluating Equipment/ Material Faults, evaluation is made but not limited to the following
    activities;
     Security measures (equipment protectors etc.)
     Appropriate equipment and materials
     Appropriate usage
     Leakages (solid-liquid-gas)
     Revision control
     Maintenance control
     Hazardous materials (chemicals etc.)

    4. While evaluating Method Faults, evaluation is made but not limited to the following activities;
     Regulatory compliance
     Standard requirements (documentation adequacy)
     Design defects
     Analysis/ Measurements

    Person in charge of the action conveys the result of root cause analysis in CAPA Plan. According to the
    result of root cause analysis, he/she plans the action for the prevention of the reoccurrence of
    nonconformity and records it in CAPA Form.
    The original form of the root cause analysis form is submitted to Quality Manager together with CAPA
    Form.

    5.4 Closure of Corrective and Preventive Actions

    When Quality/HSE Admin is sure that the action met the purpose and reoccurrence was removed, he/she
    verifies the action in the field and provides the closure of CAPA. This verification process is made by
    Departmental HSE Responsible in the field. He/she explores CAPA within the scope of IMS and makes
    necessary standardizations. For the CAPAs that are not completed in scheduled time, approval of
    “Additional Time” is got from Quality Manager. Actions that are implemented in the additional time are
    processed as normal CAPA. Authorities fill the related sections in the closed CAPA Form. Electronic copy
    of the closed CAPA Form is immediately sent to the Quality Manager by Departmental HSE Responsible
    CORRECTIVE AND PREVENTIVE
    ACTIONS PROCEDURE

    for the measurement of the department performance. The originals are sent on monthly basis to Quality
    Manager for filing.
    Administrative Account presents CAPA applications applied at the entire organization in the form of table
    (CAPA Form) in Management Review and OHS Assembly meetings to all the related departments.

    When customer complaints are received, Quality Manager issues CAPA Form of the complaint and
    transmits it to the Manager of the department that is the source of the complaint. The process  works and
    concludes exactly as described above.
    Customer is continuously informed at problem-solving stages, and then the problem is completely solved;
    the work done is delivered to the customer with objective evidences. It is provided that these CAPAs are
    implemented to similar areas.

    6. RECORDS

    Record Name Person Responsible for Preservation Preservation Period

    Corrective and Preventive Action


    (CAPA) Form Quality Manager 3 years

    CAPA Follow-up Form Quality Manager 3 years


    Root Cause Analysis Form Quality Manager 3 years

    7. ATTACHMENTS

    Corrective and Preventive Action (CAPA) Form


    Corrective and Preventive Action (CAPA) Follow-up Form
    Root Cause Analysis Form

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